Table 1 Clinical trials that are relevant with cell sheets
From: The preclinical and clinical progress of cell sheet engineering in regenerative medicine
Title | Identifier | Recruitment status | Condition or disease | Materials | Phase/basic objective | Participants |
|---|---|---|---|---|---|---|
Phase I study to evaluate safety of LSCD101(cultured autologous limbal epithelial cell sheet) transplantation for limbal stem cell deficiency | NCT04773431 | Completed | Limbus corneae/limbus corneae insufficiency syndrome | LSCD101 (cultured autologous limbal epithelial cell sheet) | Safety | 6 |
Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy | NCT04696328 | Recruiting | Myocardial ischemia | Human (allogeneic) iPSCs derived-cardiomyocyte sheet | Safety efficacy | 10 |
Safety and efficacy study of cells sheet-autologous chondrocyte implantation to treat articular cartilage defects (CS-ACI) | NCT01694823 | Recruiting | Osteochondritis/osteochondritis dissecans/joint diseases | Cells sheet-autologous chondrocyte (CS-AC) | Safety efficacy | 10 |
autologous cell sheets transplantation after ESD in the esophagus | NCT02455648 | Completed | Barrett esophagus | Autologous oral mucosal epithelial cell sheet | Efficacy | 10 |
Transplantation of autologous oral mucosal epithelial stem cell sheet for treating limbal stem cell deficiency disease | NCT03015779 | Enrolling by invitation | Limbal stem cell deficiency | Cultured autologous oral mucosal epithelial cell sheet | Efficacy | 7 |
Human (autologous) oral mucosal cell sheet transplantation after ESD in patients with superficial esophageal cancer | NCT02866019 | Completed | Superficial esophageal cancer | Human (autologous) oral mucosal cell sheets (CLS2702C/CLS2702D) | Safety efficacy | 10 |
Cultured autologous oral mucosa epithelial sheet for the treatment of bilateral limbal stem cell deficiency | NCT03949881 | Recruiting | Total bilateral limbal cell deficiency | Autologous oral mucosa epithelial sheet (autologous jugal mucosa cell sheet, FEMJA) | Tolerance efficacy | 40 |
Clinical trial on the effect of autologous oral mucosal epithelial sheet transplantation | NCT02149732 | Available | Limbal stem cell deficiency/Stevens–Johnson syndrome/ocular cicatricial pemphigoid/chemical burn | Cultured autologous oral mucosal epithelial sheet | Efficacy | ? |
Transplantation of autologous oral mucosal epithelial sheets for limbal stem-cell deficiency | NCT02415218 | Completed | Limbal stem-cell deficiency | Autologous oral mucosal epithelial sheets | Safety efficacy | 6 |
Periodontal ligament stem cell implantation in the treatment of periodontitis | NCT01082822 | Active, not recruiting | Chronic periodontitis | Periodontal ligament stem cell (PDLSC) sheet | Safety efficacy | 80 |
Implement of autologous skeletal myoblast cell sheet transplantation for dilated cardio myopathy aiming precision medicine (implement of autologous skeletal myoblast cell sheet transplantation for dilated cardiomyopathy aiming precision medicine) | JPRN-jRCTb050200131 | Recruiting | Dilated cardiomyopathy | Autologous skeletal myoblast cell sheet | Safety efficacy | 4 |
Multicenter trial of autologous nasal mucosal epithelial cell sheets for chronic middle ear inflammatory disease (middle ear cholesteatoma) | JPRN-jRCT2033210438 | Recruiting | Chronic middle ear inflammatory disease (middle ear cholesteatoma) | Autologous nasal mucosal epithelial sheets | Safety efficacy | 12 |
Clinical trial of human (allogeneic) iPS cell-derived cardiomyocytes sheet for ischemic cardiomyopathy (Follow-up trial) | JPRN-jRCT2053220055 | Recruiting | D017202 Ischemic cardiomyopathy | iPSCs-derived cardiomyocytes sheet | Safety efficacy | 10 |
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency | UMIN000036539 | Complete: follow-up continuing | Limbal stem-cell deficiency | iPSCs-derived corneal epithelial cell sheet (iCEPS) | Safety efficacy | 4 |
Long-term follow-up of the multicenter investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency | UMIN000039992 | Complete: follow-up complete | Limbal stem-cell deficiency (LSCD) | Autologous oral mucosal epithelial cell sheet (COMET01) | Safety efficacy | 6 |
Clinical trial of human (allogeneic) induced pluripotent stem cell-derived cardiomyocyte sheet for severe cardiomyopathy | UMIN000032989 | Complete: follow-up complete | Ischemic cardiomyopathy | Human (allogeneic) iPSCs-derived cardiomyocyte sheet | Safety efficacy | 3 |
Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia | UMIN000034566 | Recruiting | Congenital esophageal atresia | Autologous oral mucosal epidermal cell sheet | Safety efficacy | 5 |
A phase I/IIa safety and efficacy study of allogeneic periodontal ligament-derived mesenchymal stromal cell sheet product (TWP-0001) in patients with periodontitis, consisting of 1 wall intrabony defect, Class III furcation defect, or horizontal defect, with probing depths of 4–9 mm after the initial therapy | UMIN000034310/ JMA-IIA00391 | Complete: follow-up continuing | Periodontitis | Allogeneic periodontal ligament-derived mesenchymal stromal cell sheet (TWP-0001, periodontal ligament stem cell sheet) | Safety efficacy | 6 |
Clinical trial related with transplantation therapy with human autologous cell mixed sheets for refractory cutaneous ulcer | UMIN000031645 | Recruiting | Refractory cutaneous ulcer | human autologous cell mixed cell sheet (fibroblasts and peripheral blood mononuclear cells) | Safety | 6 |
Sealing of lung air leaks by fibroblast sheets | UMIN000022554 | Complete: follow-up complete | Pneumothorax, bullae, benign lung tumors | Autologous fibroblast sheets | Safety | 5 |
Tissue-engineered cultured periosteum used with platelet-rich plasma and hydroxyapatite in treating human osseous defects: second phase of clinical trial | UMIN000018788 | Complete: follow-up complete | Chronic periodontitis | Cultured alveolar bone‐derived periosteal sheet | Safety efficacy | 30 |
Multicenter Investigator-initiated clinical trial using cultivated autologous oral mucosal epithelial cell sheet (COMET01) transplantation for patients with limbal stem-cell deficiency | UMIN000018662 | Complete: follow-up complete | Limbal stem-cell deficiency | Autologous oral mucosal epithelial cell sheet (COMET01) | Efficacy | 6 |
Autologous myoblast sheets transplantation therapy for cardiomyopathy | UMIN000012906 | Complete: follow-up continuing | Dilated cardiomyopathy, Ischemic cardiomyopathy | Autologous skeletal myoblast sheet | Safety efficacy | 40 |
Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency | UMIN000012264 | Complete: follow-up continuing | Corneal epithelial stem cell deficiency | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency | UMIN000012260 | Complete: follow-up complete | Corneal epithelial stem cell deficiency | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
Safety and efficacy of transplantation of oral mucosal epithelial cell sheets in preventing formation of strictures after ESD | UMIN000010251 | Complete: follow-up complete | Superficial esophageal cancer | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
A study of transplantation of autologous induced pluripotent stem cell (iPSC) derived retinal pigment epithelium (RPE) cell sheet in subjects with exudative age-related macular degeneration | UMIN000011929 | Complete: follow-up complete | Exudative age-related macular degeneration (AMD) | Autologous iPSCs-derived RPE sheets | Safety | 6 |
Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease | UMIN000008013 | Complete: follow-up complete | Severe heart failure due to chronic ischemic heart disease | Autologous skeletal myoblast sheet | Safety efficacy | 6 |
Clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer | UMIN000026506 | Recruiting | Esophageal stricture after ESD | Autologous oral mucosal epithelial cell sheet | Safety | 6 |
The clinical study for the joint treatment by allogeneic cell sheet | UMIN000015205 | Complete: follow-up continuing | Cartilage defects associated with osteoarthritis of the knee | Chondrocyte sheet | Safety efficacy | 10 |
Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency | UMIN000006745 | Complete: follow-up complete | Corneal epithelial stem cell deficiency | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
The clinical study for the joint treatment by cell sheet | UMIN000006650 | Complete: follow-up complete | Traumatic and/or degenerative cartilage defect of the knee joint | Autologous chondrocyte sheets | Efficacy | 10 |
Development of new strategy for severe heart failure using autologous myoblast sheets | UMIN000003273 | Complete: follow-up complete | Ischemic cardiomyopathy, dilated cardiomyopathy | Autologous skeletal myoblast sheet | Safety efficacy | 16 |
Periodontal regeneration with autologous periodontal ligament cell sheets | UMIN000005027 | complete | Periodontitis | Autologous periodontal ligament cell sheets | Safety efficacy | 10 |
Cultivated epithelial sheet transplantation for corneal epithelial stem cell deficiency | UMIN000002948 | Complete: follow-up complete | Corneal epithelial stem cell deficiency | Corneal epithelial sheet | Safety efficacy | 5 |
Clinical trial of cultivated autologous oral mucosal epithelial cell sheet transplantation for corneal epithelial stem cell deficiency | UMIN000005400 | Complete: follow-up complete | Bilateral corneal epithelial stem cell deficiency | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
Treatment of artificial esophageal ulcerations after EMR by endoscopic transplantation of autologous oral mucosal epithelial cell sheets | UMIN000000473 | Complete: follow-up complete | Artificial esophageal ulcerations after EMR | Autologous oral mucosal epithelial cell sheet | Safety efficacy | 10 |
Clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer | UMIN000038051 | Complete: follow-up complete | Esophageal narrowing after ESD | Autologous oral mucosal epithelial cell sheet | Safety | 6 |
Phase I Study to Evaluate Safety of LSCD101(cultured autologous limbal epithelial cell sheet) transplantation for limbal stem cell deficiency | KCT0004741 | Recruiting | Diseases of the eye and adnexa | LSCD101 (cultured autologous limbal epithelial cell sheet) | Safety | 6 |
Clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer | jRCTb070190053 | Recruiting | Esophageal stricture after ESD | Autologous oral mucosal epithelial cell sheet | Safety | 6 |
Clinical study on the regenerative therapy for articular cartilage using autologous cell sheets | jRCTb030190166 | Recruiting | Cartilage defects associated with osteoarthritis of the knee | Autologous chondrocyte sheet | Safety efficacy | 20 |
A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the steroid administration risk group | jRCT2063200048 | Recruiting | Superficial esophageal cancer after ESD | Human (autologous) oral mucosal cell sheets (CLS2702C/CLS2702D) | Efficacy | 17 |
Realization for regenerative therapy of middle ear mucosa by using autologous nasal mucosal epithelial cell sheets | JMA-IIA00316 | Completed | Middle ear cholesteatoma, adhesive otitis media | Autologous nasal mucosal epithelial sheets | Safety efficacy | 10 |
First-in-human clinical research of iPS derived corneal epithelial cell sheet transplantation for patients with limbal stem-cell deficiency | jRCTa050190084 | Not Recruiting | Limbal stem-cell deficiency | iPSCs-derived corneal epithelial cell sheet | Safety efficacy | 4 |
Autologous cell mixed sheets transplantation for refractory cutaneous ulcer | jRCTb060190034 | Recruiting | Venous skin ulcer | Human autologous cell mixed cell sheet (fibroblasts and peripheral blood mononuclear cells) | Safety efficacy | 6 |